New lidocaine formulation for managing postoperative pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates a new sustained release lidocaine formulation, ST-01, for its effectiveness in controlling postoperative pain following various pelvic and perineal surgeries. Participants will receive either the new formulation or standard care after surgery, and their pain levels and opioid consumption will be monitored over 30 days. The goal is to determine if ST-01 can provide longer-lasting pain relief compared to traditional lidocaine injections. The study will involve up to 120 subjects who will be randomized to receive either treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Any sex, aged ≥ 19 years
* Indication to undergo an operation with a planned pelvic incision
* Able and willing to provide informed consent
* Stated willingness to comply with all study procedures and availability for the duration of the study
* If sexually active, is willing to use adequate birth control methods to prevent pregnancy over the course of the study

Exclusion Criteria:

* History of chronic pain conditions associated with the use of opioids or steroids
* Known allergic reactions to any components of the investigational product
* Active infection involving the surgical site
* Any contraindication to local anesthesia with lidocaine (e.g., known hypersensitivity to anesthetics of the amide type, known hypokalemia, complete heart block, anticoagulants (ASA permitted) antiarrhythmic medication)
* Use of prohibited medications (quinidine, procainamide, disopyramide, lidocaine, mexiletine, flecainide, propafenone, amiodarone, dronedarone, ibutilide, dofetilide, sotalol, vernakalant)
* Has participated in another clinical trial within 3 months prior to the Screening Visit or is planning to participate in another clinical trial during this trial period
* Has any other surgical or medical condition that, in the judgment of the clinical Investigator might warrant exclusion or be contraindicated for safety reason

Where it's running

• Vancouver Prostate Centre
  Vancouver, British Columbia, Canada Recruiting
• St. Pauls Hospital
  Vancouver, British Columbia, Canada Recruiting

Study contacts

• Study coordinator: Lesley Parker
• Email: lparker@sustainedtx.com
• Phone: 604 875 5594

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.